REQUEST FOR PROPOSAL / INVITATION TO TENDER NO. 2 OF REGARDING A TABLET PRESS LINE

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1 REQUEST FOR PROPOSAL / INVITATION TO TENDER NO. 2 OF REGARDING A TABLET PRESS LINE Public limited company Medicofarma Spółka Akcyjna, following the principle of competitiveness currently in force, hereby invites Tenderers to submit tenders for equipment delivery within the framework of the project titled Creation of a Research and Development Laboratory of Medicofarma S.A., in line with the terms and conditions defined in the present request for proposal. I. Data identifying the Awarding Entity Medicofarma S.A. ul. Sokołowska 9 office U Warsaw NIP: Statistical registration number (Regon): National Court Register (KRS) number: The Awarding Entity s contact person for the purposes of the Request for Proposal: Alicja Jabłońska, tel. (+48) II. Procedure for awarding the contract The contract in excess of the net amount of PLN 50 thousand will be awarded in accordance with the principle of competitiveness and with the Guidelines on Eligibility of Expenditures Within the Framework of the European Regional Fund, the European Social Fund and the Cohesion Fund for the Years (Ministry of Infrastructure and Development). The present procurement is not governed by the Public Procurement Act. The present Request for Proposal has been sent to potential Tenderers so that the most advantageous tender can be selected. The present Request for Proposal is also available in the Awarding Entity s office in Warsaw at ul. Sokołowska 9 office U19 and on the following website:

2 The procurement covered by the present procedure is co-financed by the European Union within the framework of the European Regional Development Fund. III. Designation of the project within the framework of which this procurement is made 1. Project title: Creation of a Research and Development Laboratory of Medicofarma S.A. 2. Name of Operational Programme: Smart Growth Operational Programme 3. Name of priority axis: Priority axis II Support for the environment and capacity of enterprise for R&D&I activity 4. Name and number of measure: Measure 2.1 Support for investment in R&D infrastructure of enterprises 5. Project co-financed from the European Regional Development Fund and the government funds. IV. Description of the object of contract Object of contract as per the codes of the Common Procurement Vocabulary: industrial machinery 1. Required delivery date: up to 12 months after conclusion of the contract 2. Place of delivery: Radom, ul. Tarnobrzeska The object of the contract is delivery of a tablet press line with additional equipment including: two hoppers, tablet press line deduster, metal detector with ejection system, system to measure a tablet's hardness, weight and height, tablet deduster, system for powder loading. The machine is an item of process equipment for manufacture of products in the form of bi-layered and traditional tablets

3 4. The tablet press line with additional equipment shall be the object of a financial lease agreement, and the Contractor shall sell the machine to a reputable leasing company selected by the Awarding Entity. 5. The object of the contract should come from current production offering of machines previously used as exhibits or leased is not allowed. 6. The object of the contract includes supplying, packing and delivery on the CIP Radom, INCOTERMS 2010 basis (carriage and insurance paid to the seat of the Awarding Entity) installation (assembly), commissioning, installation qualification, operational qualification, performance qualification (IQ/OQ), training personnel in the use and operation at the Awarding Entity s facility, provision of user manual. 7. In the event that any trademarks or origin designation have been used in the description of the object of the contract, the Awarding Entity allows the use of other appliances, equipment, materials, subassemblies, etc., which must be technically and operationally equivalent. The Contractor shall bear the burden of proof as regards the technical parameters of the offered equivalent products and appliances being in accordance with the requirements of the Awarding Entity. As proof of the equivalence of the offered items, the Contractor shall append data identifying the manufacturer of the same to the tender, so as to confirm equivalence of the offered equipment with the Awarding Entity s requirements, including as far as possible indication of a customer for which the Contractor has previously implemented the same solutions. 8. For the purposes of performance of the object of the contract, the Contractor shall be entitled to enlist the services of subcontractors. 9. The Tenderer undertakes to perform any warranty and post warranty repairs at the user s facility. The Tenderer shall be obliged to maintain a service on the territory of the Republic of Poland or another Member State of the European Union or cooperate with another entity providing such service to the Tenderer, for the offered equipment, located on the territory of the Republic of Poland or another Member State of the European Union. The required service response time must not be longer than 48 hours after notification, excluding public holidays

4 10. The Awarding Entity allows the manufacturer s own technical materials which confirm the offered technical properties to be appended to the tender documents regarding the offered machine (also in English). 11. Partial bids are not allowed V. Conditions for participation in the tender procedure 1. Award of the contract may be sought by natural persons performing business activity or legal person, who meet the following criteria: a) they hold the licences necessary to perform specific business or activities where such licences are mandatory under provisions of law in force, b) they have the respective expertise and experience, c) they have at their disposal appropriate technical resources and human resources to be able to perform the contract, d) their economic and financial standing is sufficient for the performance of the contract. 2. The Awarding Entity shall assess whether the aforesaid criteria have been met based on the documents and declarations appended to the tenders, applying the met or not met classification. Failure to meet any one of the aforesaid criteria shall result in excluding the Tenderer from the procedure and rejecting their tender. 3. Insofar as, in demonstrating that the criteria for participation in the tender procedure are met, a Tenderer should refer to resources held by third parties which will be involved in performance of the contract, the Tenderer shall submit a written declaration of any such third party undertaking to place the necessary resources at the Tenderer s disposal for the duration of the same being used in performance of the contract. 4. Tender validity period: Tenderers shall remain bound by their respective tenders for a period of 60 days after expiry of the time limit for submission of tenders. VI. Description of price calculation 1. All and any settlements between the Awarding Entity and the Contractor shall be in Polish zlotys (PLN). 2. The Supplier (Contractor) shall be obliged to calculate the proposed/offered price so as to include in it all costs and expenses to be incurred by the Contractor in the performance of the contract, including: costs of delivery, - 4 -

5 assembly and commissioning, and the costs of training the Awarding Entity s selected employees in use and operation of the object of the contract, and should further contain all and any fees and payments which the Awarding Entity will be obliged to cover on the ex works/the seat of the Awarding Entity basis (corresponding to CIP Radom, INCOTERMS 2010), and any other amounts payable in connection with performance of the contract. 3. The price of the object of the contract as per the tender form must be stated as the net price, the Vat amount payable and the gross price. The proposed/offered price must be stated in Polish zlotys (PLN) or euro (EUR). For tender bids denominated in euro, the average exchange rate of the Bank of Poland valid as on the day of opening of the tenders shall apply. 4. In order to determine whether a tender proposes an abnormally low price giben the object of the contract, the Awarding Entity may request that the Tenderer provide, within a time limit set by the Awarding Entity, explanations concerning elements of the affecting the price. 5. In the course of examination of tenders, the Awarding Entity shall correct the following in any tender: 1) obvious clerical errors, 2) obvious errors in calculation, taking into account the computing consequences of any such corrections made, 3) other obvious slips consisting in lack of the tender s compliance with the terms of reference, insofar as the same do not materially alter the contents of the tenders. VII. Description of criteria which the Beneficiary may apply to select the winning tender, complete with importance of the criteria The criterion applied in the present procedure for the purposes of selecting the winning tender shall be the most advantageous balance of the criteria described hereinbelow. Tenders shall be evaluated in terms of the most advantageous terms proposed by the Tenderers under each criterion: a) Price (cost) weighing factor: 60 %, b) Technical evaluation weighing factor: 40 % - 5 -

6 Score-based evaluation of individual criteria shall be carried out in accordance with the following principles: Re: a) Each evaluated tender will be awarded the number of A on points, calculated as follows: Minimum tender price A on = x 100 points x 0.60 Price of the tender under evaluation Re: b) The Awarding Entity shall evaluate the compliance of the machines offered with the requirements set out in the Table Statement of parameters hereinbelow. Each evaluated tender will be awarded the number of B on points, calculated based on the following principles: o the tender proposing a machine which meets the minimum requirements defined in column 3 of the Table will be awarded B 1 = 0 points, o tenders with desired higher parameters (above the required minimum), as defined below in column 4 of the Table, will be awarded a respective additional number of B 2 points (up to a maximum of 100 points). Column 5 defines the criteria for awarding points. o Each evaluated tender will be awarded the number of B on points, calculated as follows: B on = B 1 + B 2 x 0,40 Table. Statement of parameters for tender evaluation N o. Name of the subject-matter of the contract MINIMUM REQUIREMENTS DESIRED VALUES ADDITIONAL POINTS A. Basic unit 1 Tablet press line a) dimensions no more than: - height (including hopper) [cm] - width [cm] - depth [cm] b) weight no more than 7,000 kg (design enabling it to be set directly on the ceiling with load-bearing - 6 -

7 capacity of 10 tonnes/m 2 ) c) output rate of bi-layer tablets no less than (can be higher): 40,000 [pcs./h] 80,000 [pcs/h] 10 points per every 20,000 over and above 40,000, no more than 20 point in total. d) possibility of bi-layer tablets production e) turret for EU-B dies and punches with possibility of shape tablet production f) pre-pressure no less than 10 kn and main pressure no less than 80 kn pre-pressure no less than 30 kn and main 8 pkt. points per every 10 kn over and pressure no above 10 kn, less than 100 kn no more than 16 point in total.(prepressure) 8 pkt. points per every 10 kn over and above 80 kn, no more than 16 point in total.(main) g) must offer possibility of operation with part of dies closed h) possibility of step-less output rate adjustment (from 20,000/h) i) safety switch and limit switches for guards j) connection of metal detector - 7 -

8 k) manufacture of: elements to be in contact with products of: - materials approved to be in contact with food products confirmed by the certificate, - steel AISI 316 L mirror finish Ra 0.4 of surfaces to be in contact with product (confirmed by the certificate of measurement); external elements of steel AISI 304, brushed external surfaces, roughness Ra 0.8 B. Other elements/equipment included in the price 1. Important machine components a) replaceable turret with integrated or external arm for dismounting and trolley for turret transportation b) set of punches and dies for round tablets plus spare 2 pcs. c) device to provide a hopper with a certain amount of powder ensuring proper liquidity (constant amount/level feeder) and system to control powder level in hoppers d) two hoppers 2. Machine a) tablet deduster peripherals b) metal detector with ejection system c) system to measure a tablet's hardness, weight and height possibility of modification of 4 additional points if it is respective functional possible modify to parameters of respective the tablet press line functional parameters of the tablet press - 8 -

9 line d) equipment listed in items 'a' through 'c': - may be provided as functionally interconnected - may be provided as independent devices - should be adapted to maximum capacity of tablet press line 2 functional interconnection s 8 point per each option of functional connection, no more than 16 point in total. e) tablet press line deduster f) system for powder loading to both feeders, adapted to a room with the height of up to 350 cm: - vacuum-type Or -drum lifter with container a capacity of l 3. Qualification Model FAT/SAT and IQ/OQ protocols in accordance with cgmp. 4. Documentation ) a) factory technical data including: - real capacity for assumed operational parameters, - weight of the equipment (for transport, installation and during operation), - list of the required devices and accessories necessary to ensure proper operation of tablet press line, - tablet press line installation conditions ensuring its safe installation on the site, and layout including connections to external systems, - demand for utilities, ) - total area of elements to be in contact with the product. b) declaration of execution quality in accordance with cgmp - 9 -

10 c) list of control and measurement equipment with criticality analysis and certificates for metrological activities required in the EU member states. C. Accessories and consumables 1 Complete list of consumables Provision of consumables for min. 2 years of operation. D. Control system 1. System description 2. Type of controllers E. Other HMI System meeting the requirements of 11 CFR 21 part (PLC control, touch screen with colour display, menu available at least in Polish). Control based on Siemens controllers - minimum S7. 1. Formal and Confirmations of execution in legal accordance with the relevant requirements legislation in force within the European Union certificates and approvals (CE) for the machines offered 2. Warranty Min. 12 months from the operational qualification completion date. 24 months after 10 points per every completion of additional 6 operational qualification. months warranty, of no more than 20 point in total. 3. Operation manual 4. Personnel training Hardcopy and electronic version, both in Polish, and English. Personnel training in device and software operation, and maintenance works in the Awarding Entity's plant

11 5. Marking a) Inscriptions on data plate and descriptions of components/spare parts in either Polish, or English. b) Inscriptions on information and warning labels in Polish 6. Company's The company has been experience in manufacturing tablet presses with the procurement area equipment for at least 10 years The company has been manufacturing tablet presses with equipment for at least 20 years. 4 points for each additional 5 years more than the min. 10 years; no more than 8 point in total In the event that the Tenderer should fail to provide manufacturer s information materials confirming the desired parameters stated in the tender, the Awarding Entity shall not award additional points for this parameter. VIII. Selection of the winning tender The winning tender will be selected with due diligence, in line with the principles of fair competition, impartiality, objectivity, effectiveness and transparency. Lack of reference in the tender to any of the points-awarding criteria, as listed in section VII, will result in 0 points being awarded for the given criterion. The Awarding Entity will select the winning tender based on the criteria described in section VII, upon calculation of the assessment factor (W) according to the following formula: W = A on + B on The winning tender will be the one with the highest W value. In the event that selection of the winning tender should be impossible due to a tied result of the evaluation, the Awarding Entity will hold negotiations with the Tenderers. In the event that the Tenderer whose proposal has been selected as the winning tender should evade undertaking a legal obligation to perform the contract, the Awarding Entity reserves the right to select the winning tender from among the other tenders submitted. In the event that the price of performance of the contract proposed in the submitted tenders should exceed the value of funds allocated for this purpose, selection of tenders

12 may be annulled or additional price negotiations may be held with no more than three Tenderers who were awarded the highest number of points in the evaluation process. IX. Description of the tender preparation 1. Each Tenderer can submit only one tender (no variants allowed) on the pain of being excluded from the tender procedure. 2. The Tenderer shall bear all costs related to preparation and submission of the tender. 3. The Tender should be signed by persons authorized to represent the Tenderer. In the event that the tender should be signed by any person not authorized to represent the Tenderer as per respective commercial register entries documented with a certified copy thereof, the original or a certified copy of a respective power of attorney granted to represent the Tenderer in the procedure and valid as on the day of tender submission procedure must be appended. 4. The tender must be executed in writing in Polish or English, and its form must ensure complete legibility thereof. All sheets/pages must be numbered. 5. All documents and declarations in a form other than original (such as certified copies and photocopies of documents) must be authenticated in writing with an annotation stating certified true copy and a handwritten signature affixed by the Tenderer or (a) person(s) authorized to represent the Tenderer. 6. In the event that any documents appended to a tender are executed in a foreign language (which includes documents submitted by a foreign Tenderer), it is required that a translation of the same, certified by the Tenderer, be submitted. 7. The proposed/offered price must be stated in a numerical form and in words. 8. Form of payment: irrevocable Letter of Credit issued by the lessor s bank or full payment (100%) prior to shipment. 9. All and any amendments made to the contents of the tender should be added in a legible form and additionally initialled by the persons signing the tender. In the event that any submitted photocopies of documents should be illegible or give rise to doubts as regards their authenticity, the Awarding Entity can demand that the original document or a notarized copy of the same be submitted. 10. Prior to the day of opening of the tenders, any Tenderer can amend or withdraw their tender. Any amendment or withdrawal of a tender shall require a respective written declaration of the Tenderer. Any alterations related to the contents of the tender or documents appended to the tender must be prepared, packed and addressed in the same manner as the tender. 11. Documents, declarations and information should be arranged in the following order:

13 1. Statement establishing a proxy - if applicable; 2. Tender form - Attachment 1 3. Statements about fulfilment of the conditions for the participation in the procedure Attachment 2 4. Copy of the current excerpt from the relevant register. 12. If the offer is submitted in a paper form, it must be packed in a sealed opaque envelope or similar packaging and addressed to the purchaser According to the Following formula:.. Name and address of Tenderer, telephone number Tender Delivery of tables press line with additional equipment X. Place and deadline for submission of tenders and opening of tenders 1. The tender announcement is available inan electronic form at and in paper form (hardcopy) in the Awarding Entity s registered office in Warsaw at ul. Sokołowska 9 office U Tenders (prepared in line with the template constituting appendix no. 1) should be submitted in an electronic form to: a.jablonska@medicofarma.pl or in a hardcopy form in the Awarding Entity s registered office at ul. Sokołowska 9 office U19, Warsaw. In the event that a tender is submitted in an electronic form via electronic mail as files attached to a communication, the files must be in a format which allows their contents to be read, e.g. PDF. 3. Tenders must be submitted no later than on 4 August 2016 at 4 p.m. 4. No tender submitted past the aforesaid deadline shall be considered. 5. Tenders sent by post shall qualify for the procedure insofar as they are delivered by the postal service to the Awarding Entity s registered office no later than on the day and at the time stipulated in clause 3 above

14 6. Notification on selection of the winning tender will be published in the Awarding Entity s registered office and on their website within 7 days of expiry of the deadline for submission of tenders. 7. Expected date of signing the contract: by